MAUDE Adverse Event Report: REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	00-1024-R
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by snt personnel and will be investigated by the philips complaint handling team.Philips received a complaint about the tempus pro, indicating that during transport from prague, a patient with an icd (implantable cardioverter defibrillator) was monitored using an ecg 3-lead on a tempus monitor.The monitor repeatedly displayed fiko and asystole alarms (30¿160 seconds); however, the patient remained conscious, communicative, and did not receive any icd shocks.There were no clinical signs of arrhythmia, and the events were assessed as ecg artifacts, resulting in unreliable cardiac monitoring during transport.There was no report of actual harm reported with this complaint.
Additional Manufacturer Narrative
Description and reporter information updated.Component code updated.
Event or Problem Description
This report is based on information provided by philips remote service personnel and will be investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that during patient transport from prague, a patient with an icd (implantable cardioverter defibrillator) was monitored using ecg3 on the tempus pro monitor.The device repeatedly displayed fiko and asystole alarms lasting approximately 30 to 160 seconds.The monitor displayed a fiko alert, which indicates poor ecg signal quality or lead contact interference that may result in unreliable rhythm interpretation and potential artifact-related alarms.The patient remained conscious and communicative throughout the events and did not receive any icd shocks.No clinical signs of arrhythmia were reported, and the events were assessed as ecg artifact resulting in unreliable cardiac monitoring during transport.A request for additional information regarding the incident has been sent and the response is not yet received.There was no report of actual harm reported with this complaint.
Additional Manufacturer Narrative
Product information updated.
Event or Problem Description
This report is based on information provided by philips remote service personnel and will be investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that during patient transport from prague, a patient with an icd (implantable cardioverter defibrillator) was monitored using ecg3 on the tempus pro monitor.The device repeatedly displayed fiko and asystole alarms lasting approximately 30 to 160 seconds.The monitor displayed a fiko alert, which indicates poor ecg signal quality or lead contact interference that may result in unreliable rhythm interpretation and potential artifact-related alarms.The patient remained conscious and communicative throughout the events and did not receive any icd shocks.No clinical signs of arrhythmia were reported, and the events were assessed as ecg artifact resulting in unreliable cardiac monitoring during transport.Information obtained through good faith effort indicated there was no report of actual harm reported with this complaint.
Event or Problem Description
This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that during patient transport from prague, a patient with an icd (implantable cardioverter defibrillator) was monitored using ecg3 on the tempus pro monitor.The device repeatedly displayed fiko and asystole alarms lasting approximately 30 to 160 seconds.The monitor displayed a fiko alert, which indicates poor ecg signal quality or lead contact interference that may result in unreliable rhythm interpretation and potential artifact-related alarms.The patient remained conscious and communicative throughout the events and did not receive any icd shocks.No clinical signs of arrhythmia were reported, and the events were assessed as ecg artifact resulting in unreliable cardiac monitoring during transport.Information obtained through good faith effort indicated there was no report of actual harm reported with this complaint.

• Brand Name: TEMPUS PRO
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 6XW; UK GU14 6XW
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 6XW; UK GU14 6XW
• Manufacturer Contact: sharunyan thavarajan ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 24589185
• Report Number: 3003832357-2026-100156
• Device Sequence Number: 20255986
• Product Code: MHX
• UDI-Device Identifier: 05060472441027
• UDI-Public: (01)05060472441027(11)200309
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K201746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00-1024-R
• Device Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 04/16/2026; 05/15/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/20/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown